Coated VICRYL J338HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031038998), received between Dec 10, 2019 and Feb 22, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759750 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PRODUCT WAS USED ON THE PERITONEUM WITH CONTINUOUS SUTURE. WHEN THE SURGEON PULLED THE SUTURE, THERE WAS A SNAPPING SOUND AND THE SUTURE BROKE. THERE WAS NO SENSATION THAT THE SWAGE PART OF THE NEEDLE WAS BROKEN, AND ALTHOUGH THE SURGEON LOOKED FOR IT DURING THE SURGERY, THERE WAS NO SIGN OF BREAKAGE. ANOTHER PRODUCT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363853 ↗
• MalfunctionAug 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583976 ↗
• MalfunctionJul 8, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 2/13/2021 AND SUTURE WAS USED. WHEN PASSING THE SUTURE, THE INSTRUMENTALIST REPORTS THAT THE NEEDLE THREAD IS BROKEN, SO IT IS NECESSARY TO DISCARD AND REPLACE IT. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955501 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGICAL PROCEDURE FOR ACUTE APPENDICITIS ON (B)(6) 2021 AND THE SUTURE WAS USED. THE BREAKING OF THE SUTURE OCCURRED AT THE MOMENT OF PULLING FOR THE APPROXIMATION OF THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES. ANOTHER LIKE SUTURE WAS SIMPLY USED TO CONTINUE THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046999 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGICAL PROCEDURE FOR ACUTE APPENDICITIS ON (B)(6) 2021 AND THE SUTURE WAS USED. THE BREAKING OF THE SUTURE OCCURRED AT THE MOMENT OF PULLING FOR THE APPROXIMATION OF THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES. ANOTHER LIKE SUTURE WAS SIMPLY USED TO CONTINUE THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046986 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGICAL PROCEDURE FOR ACUTE APPENDICITIS ON (B)(6) 2021 AND THE SUTURE WAS USED. THE BREAKING OF THE SUTURE OCCURRED AT THE MOMENT OF PULLING FOR THE APPROXIMATION OF THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES AS ANOTHER LIKE SUTURE WAS SIMPLY USED TO CONTINUE THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006098 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE POPPED OFF SUTURE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THE ACTUAL SUTURE WAS DISCARDED. THIS IS ALL THE INFORMATION KNOWN/AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448729 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE POPPED OFF SUTURE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THE ACTUAL SUTURE WAS DISCARDED. THIS IS ALL THE INFORMATION KNOWN/AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448717 ↗